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AETOS Shoulder System

by Smith & Nephew, Inc. 2 variants

510(k) K230572

AETOS Shoulder System is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K230572 on 7 Jun 2023, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230572 Date7 Jun 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KWS
Device class
Class II
Regulation
21 CFR Part 888.3660
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K230572

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K230572
UDI-DISize and differences
AETOS Shoulder System GBP-0990-502-15F
Smith & Nephew, Inc.
GBP-0990-502-15F / GBP-0990-502-15F00885556814390
Single use: yes
On the market
AETOS Shoulder System GLS0990-506-3803E
Smith & Nephew, Inc.
GLS0990-506-3803E / GLS0990-506-3803E00885556871669
Single use: yes
On the market
AETOS Shoulder System IMP-0990-838
Smith & Nephew, Inc.
IMP-0990-838 / IMP-0990-83800885556871706
Single use: no
On the market
AETOS Shoulder System INS-0990-804L
Smith & Nephew, Inc.
INS-0990-804L / INS-0990-804L00885556811603
Single use: no
On the market
AETOS Shoulder System INS-0990-804S
Smith & Nephew, Inc.
INS-0990-804S / INS-0990-804S00885556811597
Single use: no
On the market
AETOS Shoulder System SPC-0990-204-L
Smith & Nephew, Inc.
SPC-0990-204-L / SPC-0990-204-L00885556871690
Height 9 mm
Single use: yes
On the market
AETOS Shoulder System SPC-0990-204-S
Smith & Nephew, Inc.
SPC-0990-204-S / SPC-0990-204-S00885556871683
Height 9 mm
Single use: yes
On the market

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